EUCTR2013-001650-94-GB进行中（未招募）1 期
An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature Ejaculation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 59
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •· written informed consent has been obtained from both the patient and his female partner
- •· male aged 18 to 50 years
- •· in a stable monogamous sexual relationship with a female partner for at least 6 months (with the
- •intention to continue with the same partner for the duration of the study)
- •· diagnosed with lifelong PE (defined as symptoms starting at the time the patient became sexually
- •· meets PE criteria (based on the 2008 International Society of Sexual Medicine [ISSM] definition)
- •· previously tried at least one form of therapy for PE (eg, behavioral therapy, topical therapy, or oral
- •therapy) but patient remains dissatisfied
- •· mean screening intravaginal ejaculatory latency time (IELT) of = 1 minute (calculated from the 4 most
- •recent evaluable events recorded on the screening sexual event log [SEL])
- •-None of the 4 most recent evaluable events can have an IELT measurement > 2 minutes.
- •-It must not have taken longer than 28 days to obtain 4 evaluable events.
- •-Evaluable event is defined as an ejaculation which was recorded in the SEL to have occurred
- •prior to intended vaginal penetration or during vaginal penetration (see Section 6.3.4.1 for
- •further details).
- •· patient and partner are willing and able to engage in vaginal intercourse at least 4 times per month for
- •the duration of the study
- •· patient and partner agree not to change their usual sexual practices during the study (eg, amount of
- •foreplay, use of lubrication, use of behavioral techniques, and/or type of contraception)
- •· patient and partner agree not to use condoms for the duration of the study (screening and
- •posttreatment)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •· any medical or surgical condition that could be associated with secondary (acquired) PE or patient has
- •PE which is situational or attributable to relationship issues
- •· a score of < 25 on the International Index of Erectile Function - Erectile Dysfunction (IIEF-ED)
- •questionnaire at screening
- •· patient is unable or unwilling to discontinue (ie, washout) prohibited medications from at least 28 days
- •prior to efficacy measurements, and throughout the duration of the study. Prohibited medications
- •1) dapoxetine (Priligy™, Kutub™) or any other medications with selective serotonin reuptake
- •inhibitor (SSRI) activity
- •2) tramadol or any other medications with serotonin norepinephrine reuptake inhibitor (SNRI)
- •activity or with opiate activity
- •3) antidepressant, antipsychotic, antiepileptic, neuroleptic medications, or medications with
- •psychoactive properties
- •4) topical penile treatments (eg, anesthetics, herbal treatments) for PE or any other indication
- •5) penile injections (eg, intracavernosal injections) for PE or any other indication
- •6) phosphodiesterase type 5 (PDE-5) inhibitors, alprostadil, or any other treatments for erectile
- •dysfunction (ED) or any other type of sexual dysfunction
- •7) See Section 4.5.2 for a full list of prohibited medications requiring washout.
- •· patient has had prior genital, prostatic or lower urinary tract surgery (other than vasectomy or
- •circumcision)
- •· clinically significant sexual dysfunction in the female partner that could interfere with study
- •participation or impact the sexual relationship (eg, decreased libido, painful intercourse)
- •· the partner is known to be pregnant or there is an intention for the partner to become pregnant during
- •the course of the study
- •· any uncontrolled systemic disease
- •· history of any neurologic condition that may affect sexual function or findings at study entry which
- •may be consistent with a neurological condition that may affect sexual function
- •· medication in the last 6 months for depression, psychiatric disorders (including post traumatic stress
- •syndrome), mood disorders, schizophrenia, alcohol abuse, substance abuse, or anxiety disorders
- •· patient has excessive alcohol usage in the opinion of the investigator
- •· botulinum toxin therapy of any serotype for any non-urological condition or usage (eg, cosmetic,
- •chronic migraine) during the 12 weeks prior to screening, or planned usage during the course of this
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